MAUDE Adverse Event Report: CERNER CORPORATION POWERCHART TOUCH; SOFTWARE

Model Number REFER H10

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on february/06/2023 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification is available.Model number: powerchart touch server 4.21.0 through powerchart touch server 4.22.0.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's powerchart touch®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium powerchart touch, which is a mobile application that is an extension of the electronic health record (ehr).The issue affects users that utilize the powerchart touch to display and add clinical data in diagnostic and treatment decisions.In cerner millennium, when users save or sign a note, refresh a note section, or remove a note section, an error message is displayed and users may lose any unsaved changes.Patient care may be affected or delayed if documentation that is necessary to make clinical decisions is missing.Cerner has not received communication on any adverse patient events as a result of this issue.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's powerchart touch®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's millennium powerchart touch, which is a mobile application that is an extension of the electronic health record (ehr).The issue affects users that utilize the powerchart touch to display and add clinical data in diagnostic and treatment decisions.In cerner millennium, when users save or sign a note, refresh a note section, or remove a note section, an error message is displayed and users may lose any unsaved changes.Patient care may be affected or delayed if documentation that is necessary to make clinical decisions is missing.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner corporation distributed an updated flash notofication on june/8/2023 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification has been developed to address the issue for all sites that could be potentially impacted.Cerner distributed a flash notification on february/06/2023 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.D4: model number: powerchart touch server 4.21.0 through powerchart touch server 4.22.0.

• Brand Name: POWERCHART TOUCH
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 16311517
• MDR Text Key: 308945365
• Report Number: 1931259-2023-00004
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REFER H10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1